Quality Manager

ESSENTIAL FUNCTIONS PERFORMED

- Ensures that quality system regulations defined in the Code of Federal Regulations – Quality System 21CFR Part 820, ISO 13485:
2003 and JPAL are followed.
- Provides adequate resources to meet department objectives and support operations needs.
- Remove barriers which prevent objectives from being achieved and provide managerial and technical support helping others to achieve their assigned tasks.
- Provides input to the department budget and manages to that budget.
- Resolves problems ensuring that quality needs are bing met and manufacturing criteria are adhered to.
- Handles miscellaneous problems that arise, resolves problems with product quality and quality auditing procedures and coordinates the re-work of nonconforming product.
- Prepares written reports summarizing the quality status of product and systems and identifies opportunities for improvement.
- Assists and coordinates the Tech Team as required.
- Manages department personnel by interviewing, hiring, training, evaluating job performance, disciplining, scheduling work and other related responsibilities.
- Reviews risk management files to ensure new risks or risks that have exceeded there thresholds are identified and mitigated.
- Performs other related duties and tasks as required.

ESSENTIAL PHYSICAL/ENVIRONMENTAL DEMANDS

SUMMARY OF MINIMUM QUALIFICATIONS

- Educational and or work related experience equivalent to a Bachelor’s Degree in Engineering or related area, ten years of related experience, with proven management skills.
- Ability to independently apply analytical skills, complex scientific technical principles, and detailed knowledge in solving engineering problems.
- Knowledge of and ability to apply principles of supervision.
- Demonstrated interpersonal skills and the ability to delegate work.
- Attention to detail and good organizational skills.
- Problem solving and conflict management skills.
- Working knowledge of United States and international standards as applicable to the department.
- Demonstrated computer skills preferably spreadsheets, word processing, database (Oracle preferred), statistical analysis and other applicable software programs.

COMPETENCIES

COMMENTS

Infectious Control Risk Category I:

The risk category explains whether or not employees are likely to come into contact with blood or body fluids while performing their jobs. Risk category I states employment and procedures that will require exposure.

About Merit Medical

Founded in 1987, Merit Medical Systems, Inc. is a leading manufacturer and marketer of proprietary disposable medical devices used in interventional, diagnostic and therapeutic procedures, particularly in cardiology, radiology, oncology, critical care and endoscopy. Merit serves client hospitals worldwide with a domestic and international sales force and clinical support team totaling in excess of 500 individuals. Merit employs approximately 6,000 people worldwide with facilities in South Jordan, Utah;
Pearland, Texas;
Richmond, Virginia;
Aliso Viejo, California;
Maastricht and Venlo, The Netherlands;
Paris, France;
Galway, Ireland;
Beijing, China;
Tijuana, Mexico;
Joinville, Brazil;
Ontario, Canada;
Melbourne, Australia;
Tokyo, Japan;
Reading, United Kingdom;
Johannesburg, South Africa;
and Singapore.
UNDERSTAND. INNOVATE. DELIVER.
Merit Medical is a leading manufacturer and marketer of proprietary disposable medical devices used in interventional, diagnostic and therapeutic procedures, particularly in cardiology, radiology, oncology, critical care and endoscopy. Merit has made it a priority to understand customers, innovate, and deliver life-changing products and services.

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